FDA Adverse Event
Malfunction
Summary report: N
CLEAR, PVC CONTRAST INJECTION LINE
MDR report key: 1586572
·
Received January 12, 2010
Report
- Report Number
- 1721504-2010-00002
- Event Type
- Malfunction
- Date Received
- January 12, 2010
- Date of Event
- December 9, 2009
- Report Date
- December 14, 2009
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DXJ
- PMA / PMN Number
- K883718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED FOR EVAL. THE DEVICE WAS EXAMINED VISUALLY AND THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MANUFACTURING BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. COMPLAINT DATA WILL BE MONITORED TO VERIFY EFFECTIVENESS OF CORRECTIVE ACTIONS TAKEN. DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.
Description of Event or Problem · 1
THE ADAPTER RUPTURED DURING INJECTION OF CONTRAST MEDIA WHILE PERFORMING AN ANGIOPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEAR, PVC CONTRAST INJECTION LINE | DISPLAY, CATHODE-RAY-TUBE, MEDICAL | DXJ | MERIT MEDICAL SYSTEMS, INC. | F693833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA| ANGIO CATHETER - BOSTON |